创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

老年急性心肌梗死PCI患者替罗非班剂量方案的DEA模型评估

DEA Model-Based Evaluation of Tirofiban Dosing Regimens in Elderly Patients with Acute Myocardial Infarction Undergoing PCI

  • 摘要: 目的应用数据包络分析(data envelopment analysis,DEA)模型评估老年急性心肌梗死(acute myocardial infarction,AMI)患者经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)后替罗非班剂量方案的相关效率指标,为优化治疗方案提供依据。方法本研究前瞻性纳入2023年9月至2024年12月广州市红十字会医院心血管内科收治的老年AMI行急诊PCI患者278例,采用随机数字表法分为低剂量组93例、标准剂量组92例、高剂量组93例。低剂量组给予替罗非班负荷量5 μg·kg-1+维持量0.075 μg·kg-1·min-1;标准剂量组负荷量10 μg·kg-1+维持量0.150 μg·kg-1·min-1;高剂量组负荷量15 μg·kg-1+维持量0.225 μg·kg-1·min-1,均持续静脉泵注24 h。比较3组术后心肌酶学指标、心肌梗死溶栓试验(thrombolysis in myocardial infarction,TIMI)血流3级率、ST段回落≥ 50%比例、术中无复流率/慢血流发生率、主要不良心血管事件(major adverse cardiovascular events,MACE)发生率、人均药品费用、总住院费用、住院时长及冠心病监护病房(coronary care unit,CCU)停留时间。应用DEA模型,以人均药品费用、总住院费用、MACE发生率为投入指标,以TIMI3级率、ST段回落≥ 50%比例、住院时长缩短值、CCU停留缩短值为产出指标,综合评价3组方案的综合效率(θ)、纯技术效率(pure technical efficiency,PTE)及规模效率(scale efficiency,SE)。结果 3组患者术后峰值肌酸激酶同工酶MB (creatine kinase isoenzyme MB,CK-MB)、心肌肌钙蛋白T (cardiac troponin T,cTnT)等心肌酶学指标,以及TIMI血流3级率、ST段回落≥ 50%比例、术中无复流/慢血流发生率差异均无统计学意义(P > 0.05)。3组患者总MACE发生率组间比较差异无统计学意义(P > 0.05)。标准剂量组在人均药品费用、总住院费用、住院时长及CCU停留时间方面均显著优于其他2组(P < 0.05)。DEA模型评估显示标准剂量组θ显著高于其他2组(P < 0.001)。结论标准剂量替罗非班方案在保障疗效的同时,显著降低医疗成本和住院时间,θ最高。实现了疗效、安全性与经济性的最佳平衡,是老年AMI行PCI患者的最佳治疗选择。

     

    Abstract: Objective To evaluate the related efficiency indicators of tirofiban dosing regimens in elderly patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) using the data envelopment analysis (DEA) model, and to provide evidence for treatment optimization. Methods A total of 278 elderly AMI patients who received emergency PCI were prospectively enrolled from the Department of Cardiology, Guangzhou Red Cross Hospital between September 2023 and December 2024. They were assigned to the low-dose group (n = 93), the standard-dose group (n = 92) and the high-dose group (n = 93) using the random number table method. The low-dose group received a tirofiban loading dose of 5 μg·kg-1 followed by a maintenance dose of 0.075 μg·kg-1·min-1; the standard-dose group received a loading dose of 10 μg·kg-1 followed by a maintenance dose of 0.15 μg·kg-1·min-1; the high-dose group received a loading dose of 15 μg·kg-1 followed by a maintenance dose of 0.225 μg·kg-1·min-1. All patients received continuous intravenous pump infusion for 24 hours. Postoperative myocardial enzymes, thrombolysis in myocardial infarction (TIMI) grade 3 flow rate, proportion of ST-segment resolution ≥ 50%, incidence of intraoperative no-reflow or slow flow, incidence of major adverse cardiovascular events (MACE), average drug cost per patient, total hospitalization cost, length of hospital stay and coronary care unit (CCU) stay duration were compared across the three groups. The DEA model was used to comprehensively evaluate the comprehensive efficiency (θ), pure technical efficiency (PTE) and scale efficiency (SE) of the three regimens, with average drug cost per patient, total hospitalization cost and MACE incidence as input indicators, and TIMI grade 3 flow rate, proportion of ST-segment resolution ≥ 50%, reduction in length of hospital stay and reduction in CCU stay duration as output indicators. Results There were no statistically significant differences among the three groups in postoperative peak myocardial enzymes, including creatine kinase isoenzyme MB (CK-MB) and cardiac troponin T (cTnT), as well as TIMI grade 3 flow rate, proportion of ST-segment resolution ≥ 50% and incidence of intraoperative no-reflow or slow flow (P > 0.05). No statistically significant difference was observed in the overall incidence of MACE among the three groups (P > 0.05). The standard-dose group was significantly superior to the other two groups in average drug cost per patient, total hospitalization cost, length of hospital stay and CCU stay duration (P<0.05). DEA evaluation showed that the θ value of the standard-dose group was significantly higher than that of the low-dose and high-dose groups (P<0.001). Conclusion The standard-dose tirofiban regimen can ensure clinical efficacy while significantly reducing medical costs and shortening hospital stay, with the highest θ value. It achieves the optimal balance of efficacy, safety and cost-effectiveness, and is the preferred treatment regimen for elderly AMI patients undergoing PCI.

     

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